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Completed

NCT Number: NCT01018394

Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 18 years of age;
  • no intention of quitting in the next one month;
  • report ST as their primary tobacco of use;
  • have used ST daily for the past 12 months;
  • have been provided with, understand, and have signed the informed consent
  • are able to complete all study visits;
  • are in general good health as determined by medical history.

Exclusion criteria

  • currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program;
  • currently enrolled in another research study;
  • describe having a medical history of: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
  • have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];
  • have another member of their household already participating in this study;
  • have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators;
  • have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen;
  • are currently pregnant are trying to become pregnant;
  • are currently breast-feeding and unwilling to stop during this study.

Treatment and study plan

Nicotine Lozenges

Drug

4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.

tobacco-free snuff

Drug

Tobacco-free snuff used ad lib for a maximum of 12 weeks

Primary outcomes

  1. Tobacco Abstinence at 12 Weeks

    Time frame: week 12

    Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.

Other outcomes

  1. Smokeless Tobacco Reduction Greater or Equal to 50%

    Time frame: baseline, week 4

    Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 23, 2009
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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